A Proposal of a Combined Convergence Regulatory Strategy Applied to Post-approval Changes by Latin American Countries, Reducing Workload and Allowing Continuous Improvement to Guarantee the Quality, Safety, and Efficacy of Medicines.

Heraclio Rodriguez,Maria Lucia De Lucia

doi:10.3389/fmed.2021.768376

Abstract

In recent years, post-approval changes (PACs) for medicinal products have increased faster than the national regulatory agencies can attend to without causing any negative impact. This study presents a proposal for regulatory management based on our analysis of the data available from the national regulatory agencies of Latin America on the total post-approval changes evaluated, and the time spent in the process. A retrospective search on the official websites of competent national regulatory authorities (NRAs) of 14 Latin American countries (México, Guatemala, Nicaragua, Honduras, El Salvador, Panamá, Costa Rica, Venezuela, Colombia, Ecuador, Peru, Argentina, Chile and Brazil) was conducted to collect data on post-approval changes in the last 4–6 years, up to January 2021. The NRAs considered were Brazil, México, Colombia, and Costa Rica. Our analysis was focused on the post-approval changes that required approval before implementation, those that were submitted, and those that were submitted and approved for small molecules, biologics, and biotechnological products. The results indicated differences in the regulatory processes and procedures applied by the different agencies. We also found that the implementation of the PACs was directly impacted by limited resources, which puts the medication supply for chronic treatments at risk resulting in serious consequences for patients. For local decision-making, Latin American NRAs should implement regulatory pathways already made by regulatory agencies included in the World Health Organization Listed Authorities on PAC approval to optimize their resources and to ensure the continuity of medicine supply for their patients.

Highlights

Chemistry, Manufacturing, and Controls (CMC) changes in medicinal products are inevitable regardless of their type, category, or characteristics
In a recently published report by the Pan American Health Organization (PAHO) (3), it was declared that the marketing authorization in the Latin American national regulatory authorities (NRAs) of regional reference is a complex area, which poses a number of challenges for regulators at present and will continue to do so in the future
We systematically reviewed all available NRA official websites of Latin America (LATAM) countries

Summary

Introduction

Chemistry, Manufacturing, and Controls (CMC) changes in medicinal products are inevitable regardless of their type, category, or characteristics. The number of PACs submitted has piled up through the years, creating a large backlog that can take a significant amount of time to be cleared by even the largest and most well-funded authorities (3). This challenge demands more resources from all NRAs (who must be using their limited resources efficiently), considering that CMC processes are crucial in guaranteeing the optimal quality, safety, and efficacy of the medicines distributed in their countries. One pathway that should be covered in order to achieve optimization would be through the regulatory reliance on the assessment and approvals performed and granted by the Stringent Regulatory Authorities of the product’s manufacturing countries [described in the World Health Organization (WHO) List of Stringent Regulatory Authorities]

Methods

Results

Discussion

Conclusion